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FDA 510(k)

COMBISET OR INFUSION SET

K-Number: K830868 · 1983-04-14

ApplicantPan-Tek Intl., Inc.
Decision Date1983-04-14
Product CodeFPA
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

COMBISET OR INFUSION SET is the device name listed in this FDA 510(k) record. The listed applicant is Pan-Tek Intl., Inc.. It received FDA 510(k) clearance on 1983-04-14 under 510(k) number K830868. The device is classified under product code FPA. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the COMBISET OR INFUSION SET?

COMBISET OR INFUSION SET is a medical device that received FDA 510(k) clearance on 1983-04-14. The listed applicant is Pan-Tek Intl., Inc.. The 510(k) number is K830868.

When did COMBISET OR INFUSION SET receive FDA 510(k) clearance?

COMBISET OR INFUSION SET received FDA 510(k) clearance on 1983-04-14, under 510(k) number K830868.

Who is the listed applicant for COMBISET OR INFUSION SET?

The FDA 510(k) record lists Pan-Tek Intl., Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for COMBISET OR INFUSION SET?

The FDA product code for COMBISET OR INFUSION SET is FPA.

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Related Devices (Code: FPA)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K254123Ecomed Disposable Administration SetsEcomed Solutions, LLCK261530iiSure Infusion SetDeka Research and DevelopmentK252543AMSafe Administration Set (BA-70075, BA-70071-D, BA-70070, BA-70071-P, BA-70072, BA-70072-F, BA-70071-DF, BA-70071-DF-120, FE01, FE04)Amsino International, Inc.K251375PuraCath Firefly Needleless Connector IT (9005)Puracath Medical, Inc.K251257nSet+ Stabilization Set [6426733]; nSet+ Stabilization Set with nSyte Needle Free Connector (NFC) [6426731]; nSyte Needle Free Connector (NFC) [6426727]Np MedicalK250325BD Alaris Pump Infusion SetCarefusion (Bd)

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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